Long-Term Follow-up Study

N/AEnrolling By InvitationNCT05332054

Caribou Biosciences, Inc.150 enrolled

Overview

This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Lymphoma, Non-Hodgkin Relapsed Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Non-Hodgkin Lymphoma Lymphoma B Cell Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment * Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT * Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion. Exclusion Criteria: * None

Locations (31)

University of Alabama

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

University of California Irvine

Irvine, California, United States

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Incidence of targeted NSAEs

Time frame: 15 Years

Frequency of targeted NSAEs

Time frame: 15 Years

Duration of targeted NSAEs

Time frame: 15 Years

Outcome of targeted NSAEs

Time frame: 15 Years

Incidence of AESIs

Time frame: 15 Years

Frequency of AESIs

Time frame: 15 Years

Duration of AESIs

Time frame: 15 Years

Outcome of AESIs

Time frame: 15 Years

Incidence of targeted SAEs

Time frame: 15 Years

Frequency of targeted SAEs

Time frame: 15 Years

Duration of targeted SAEs

Time frame: 15 Years

Outcome of targeted SAEs

Time frame: 15 Years

Incidence of AEs related to IP leading to death

Time frame: 15 Years

Secondary Outcomes

Overall survival

Assessment of overall survival and disease progression as described in the SOA

Time frame: 15 years

Long-Term Follow-up Study

Overview

Conditions

Interventions

Eligibility

Locations (31)

Outcomes

Primary Outcomes

Secondary Outcomes